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临床试验/NCT01758809
NCT01758809已完成不适用

Pain Control of Thoracoscopic Major Pulmonary Resection: Is Pre-emptive Local Bupivacaine Injection Able to Replace the Intravenous Patient Controlled Analgesia?

Seoul National University Bundang Hospital2 个研究点 分布在 2 个国家目标入组 86 人开始时间: 2010年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
2
主要终点
The change in postoperative pain confirmed by Visual Analogue Pain Scale

研究概览

简要总结

The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.

详细描述

Despite less postoperative pain from Video Assisted Thoracic Surgery (VATS) than thoracotomy, pain is still an important issue in its recovery period. After VATS procedure, intravenous patient controlled analgesia (IV PCA) is being used for pain control. However, the side effects of IV PCA are nausea, vomiting, sleepiness, and urination difficulty which interrupt the early recovery. It is established that pre-emptive local bupivacaine injection is more economical, has almost no side effects, and finally, it is effective for the postoperative 24 hours. The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • patients that are expected to receive VATS segmenectomy or lobectomy regardless of disease entity

排除标准

  • not done by VATS anatomical resection
  • patient does not agree to the study
  • postoperative hospital stay exceeds 7 days due to postoperative complications
  • existence of preoperative renal insufficiency (Cr > 1.5)
  • OT/PT > 120
  • history of Lidocaine hypersensitivity

研究组 & 干预措施

Bupivacaine

Active Comparator

干预措施: Pre-emptive bupivacaine wound infiltration (Procedure)

Intravenous Patient Controlled Analgesia

Other

postoperative pain control with intravenous patient controlled analgesia

干预措施: intravenous patient controlled analgesia (Procedure)

结局指标

主要结局

The change in postoperative pain confirmed by Visual Analogue Pain Scale

时间窗: Operation day, Postoperative Day 1, 2, 3 and 2 week, 1 month, 2 months

次要结局

  • number of participants with adverse events related to fentanyl or bupivacaine drug(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sanghoon Jheon

Chief, Department of Thoracic and Cardiovascular Surgery

Seoul National University Bundang Hospital

研究点 (2)

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